Assisted Reproductive Technology Act 2007 (NSW)

Assisted Reproductive Technology Act 2007 No 69 An Act relating to the regulation of assisted reproductive technology services, the registration of assisted reproductive technology service providers and the prohibition of commercial surrogacy; and for other purposes. Part 1 Preliminary 1 Name of Act This Act is the Assisted Reproductive Technology Act 2007. 2 Commencement This Act commences on a day or days to be appointed by proclamation. 3 Objects of Act The objects of this Act are— (a) to prevent the commercialisation of human reproduction, and (b) to protect the interests of the following persons— (i) a person born as a result of ART treatment, (ii) a person providing a gamete for use in ART treatment or for research in connection with ART treatment, (iii) a woman undergoing ART treatment. 4 Definitions (1) In this Act— adult means a person who is not a child. approved form means a form approved by the Secretary. ART provider means a person who provides ART services and includes a registered ART provider, but does not include a person who provides ART services on behalf of a registered ART provider either under contract or in the course of the person's employment by the registered ART provider. ART service means any one or more of the following services, treatments or procedures that is provided for fee or reward or provided in the course of a business (whether or not for profit)— (a) an ART treatment, (b) the storage of gametes and embryos for use in ART treatment, (c) the obtaining of a gamete from a gamete provider for use in ART treatment or for research in connection with ART treatment. ART treatment means assisted reproductive technology treatment, being any medical treatment or procedure that procures or attempts to procure pregnancy in a woman by means other than sexual intercourse, and includes artificial insemination, in-vitro fertilisation, gamete intrafallopian transfer and any related treatment or procedure that is prescribed by the regulations. central register means the central register established under Part 3. certificate of authority means the certificate of authority issued to an inspector by the Secretary under Part 5. child means a person who is under the age of 18 years and not married. Department means the Ministry of Health. donated embryo—see section 4B. donated gamete—see section 4B. donor means the gamete provider from whom a donated gamete has been obtained. embryo means the single entity formed by the combination of a human sperm and a human ovum until the time it is implanted in the body of a woman. exercise a function includes perform a duty. full name, in relation to a gamete provider who is a donor, includes each name by which the gamete provider is or has been known. function includes a power, authority or duty. gamete means a human sperm or a human ovum. Note— Section 8 (b) of the Interpretation Act 1987 provides that in any Act or instrument a reference to a word or expression in the singular form includes a reference to the word or expression in the plural form. gamete provider, in relation to a gamete, means the individual from whom the gamete has been obtained and, in relation to an embryo, means an individual from whom a gamete used to create the embryo was obtained. health services provider means any of the following— (a) an ART provider or a person that has at any time been an ART provider, (b) a registered medical practitioner, a person who has at any time been a registered medical practitioner or a person who, at any time before the repeal of the Medical Practice Act 1992, was registered as a medical practitioner under that Act, (c) a public health organisation within the meaning of the Health Services Act 1997, (d) a private health facility within the meaning of the Private Health Facilities Act 2007, (e) any person or body of a class prescribed by the regulations. identifying information means information that identifies the individual to whom the information relates. inspector means a person appointed as an inspector under Part 5. non-identifying information means information that does not identify the individual to whom the information relates. obtain a gamete from a gamete provider includes receive a gamete from a gamete provider. offspring of a person means an individual to whom the person is a biological parent and includes an individual born as a result of ART treatment using the person's donated gamete. parent of a child means a person having parental responsibility for the child. parental responsibility, in relation to a child, means all the duties, powers, responsibilities and authority which, by law, parents have in relation to their children. premises includes any land or building and part of any land or building. record includes a book, account, deed, writing, document and any other source of information compiled, recorded or stored in written form, or on micro-film, or by electronic process, or in any other manner or by any other means. registered ART provider means a person registered by the Secretary under Division 1 of Part 2 as an ART provider and whose registration is in force. relevant medical history of a donor means any medical history or genetic test results of the donor or the donor's family that are relevant to the future health of any of the following— (a) persons undergoing ART treatment using the donated gamete, (b) offspring born as a result of the treatment, (c) descendants of such offspring. Secretary means the Secretary of the Department. seized item means anything seized by an inspector under Part 5. spouse of a person means— (a) a person to whom the person is legally married (including a husband or wife of the person), or (b) the person's de facto partner, but if more than one person would so qualify as a spouse, means only the latest person to so qualify. Note— "De facto partner" is defined in section 21C of the Interpretation Act 1987. surrogacy arrangement has the same meaning as it has in the Surrogacy Act 2010. Note— The Interpretation Act 1987 contains definitions and other provisions that affect the interpretation and application of this Act. (2) (Repealed) (3) Notes included in this Act do not form part of this Act. 4A References to ART treatment involving gametes A reference in this Act to ART treatment involving the use of a gamete includes a reference to ART treatment involving the use of an embryo created from a gamete. 4B References to "donated gametes" and "donated embryos" (1) A reference in this Act to a donated gamete— (a) is a reference to a gamete donated by a gamete provider for use by a person other than the gamete provider or the gamete provider's spouse, and (b) includes a reference to a gamete used to create a donated embryo (whether or not the gamete was originally obtained from the gamete provider as a donated gamete and whether or not the embryo was originally created for use as a donated embryo). (2) A reference in this Act to a donated embryo is a reference to an embryo donated after its creation for use by a person who is not— (a) one of the gamete providers from whom the gametes used to create the embryo were obtained, or (b) the spouse of one of those gamete providers. 5 Application of other legislation This Act does not limit or otherwise affect the operation of any of the following— (a) the Status of Children Act 1996, (b) the Mutual Recognition Act 1992 of the Commonwealth, (c) the Trans-Tasman Mutual Recognition Act 1997 of the Commonwealth. Part 2 ART providers Division 1 Registration Note— Section 11 of the Research Involving Human Embryos Act 2002 of the Commonwealth requires a person or body to be accredited by the Reproductive Technology Accreditation Committee of the Fertility Society of Australia or another prescribed body if the person or body intentionally uses a human embryo (other than an excess ART embryo as defined under that Act) outside the body of a woman. 6 ART providers must be registered (1) An ART provider must not provide ART services unless the ART provider is a registered ART provider. (2) A person must not advertise or hold out that the person is a registered ART provider unless the person is a registered ART provider. Maximum penalty—1,000 penalty units in the case of a corporation or 400 penalty units or imprisonment for 2 years, or both, in any other case. 7 Registration (1) A person may apply to the Secretary for registration as an ART provider. (2) An application is to be made in an approved form and be accompanied by the fee (if any) prescribed by the regulations. (3) An application must include the following— (a) the name of the applicant, (b) the address of each premises at which the applicant intends to provide ART services, (c) the name of each registered medical practitioner who is to undertake or supervise ART services provided by the applicant, (d) the name of each person who is to provide counselling services in relation to ART services provided by the applicant, (e) any other matter that is prescribed by the regulations. (4) The Secretary must grant the applicant's registration as an ART provider if an application for registration is duly made. (5) Despite subsection (4), the Secretary must refuse to grant a person registration as an ART provider if the person is prohibited under Part 6 from carrying on a business that provides ART services. (6) Registration as an ART provider takes effect when the Secretary gives the applicant notice of the decision to grant registration and remains in force until cancelled by the Secretary. (7) The Secretary must cancel a person's registration as an ART provider if— (a) the person gives the Secretary notice that the person no longer provides ART services, or (b) the person is prohibited under Part 6 from carrying on a business that provides ART services. (8) A registered ART provider must (within such times as may be prescribed) pay to the Secretary the annual registration fee (if any) prescribed by the regulations. (9) The regulations may prescribe different application fees and annual registration fees for different classes of ART providers, or on the basis of the number of premises at which an ART provider provides ART services, or both. (10) The Secretary may cancel a person's registration as an ART provider if the person fails to pay any fee as required by this section. 8 Notice of change in registered particulars (1) A registered ART provider must give notice to the Secretary of the following events or changes— (a) the ART provider ceasing to provide ART services, (b) any change of premises at which the ART provider provides ART services, (c) any change of registered medical practitioners undertaking or supervising ART services provided by the ART provider, (d) any change in the persons providing counselling services in relation to ART services provided by the ART provider, (e) any other events or changes that are prescribed by the regulations. Maximum penalty—400 penalty units in the case of a corporation or 200 penalty units in any other case. (2) Notice to the Secretary under subsection (1)— (a) is to be given before the end of the next business day after the event or change occurs, and (b) is to be given in an approved form and be accompanied by the fee (if any) prescribed by the regulations. (3) In this section— business day means any day other than a Saturday, a Sunday or a public holiday throughout New South Wales. 9 Register of ART providers (1) The Secretary is to keep a register of all ART providers registered under this Part. (2) The register is to contain the following, for each registered ART provider— (a) the name of the ART provider, (b) the address of each premises at which the ART provider provides ART services, (c) the name of each registered medical practitioner who undertakes or supervises ART services provided by the ART provider, (d) the name of each person who provides counselling services in relation to ART services provided by the ART provider. (3) The register is to contain such other matters and is to be kept in such manner and form as the Secretary may from time to time determine, subject to the regulations. (4) The Secretary is to cause the contents of the register to be made available for inspection free of charge by the public at the Department's head office and on the Department's website on the Internet. Division 2 Provision of ART services 10 Infection control standards The regulations may require an ART provider to meet such infection control standards as may be prescribed by the regulations in relation to any ART services provided by the ART provider. 11 ART services to be undertaken or supervised by a registered medical practitioner An ART provider must ensure that any ART services provided by the ART provider are undertaken by, or under the supervision of, a registered medical practitioner. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. 12 Counselling to be available (1) An ART provider must ensure that counselling services are available to any woman who seeks ART treatment from the ART provider, any spouse of such a woman and any person proposing to provide a gamete to the ART provider. Maximum penalty—50 penalty units in the case of a corporation or 25 penalty units in any other case. (2) The counselling services under subsection (1) must— (a) be available at the place where the ART treatment is provided or, in the case of a person proposing to provide a gamete, at the place where the gamete is to be provided, and (b) (Repealed) (c) be offered before the ART treatment is provided or, in the case of a person proposing to provide a gamete, before the gamete is provided. (2A) An ART provider that has possession of a gamete, or an embryo created using a gamete, that was not originally obtained from the gamete provider as a donated gamete must ensure that counselling services are made available to the gamete provider if the gamete provider proposes to donate the gamete or embryo for use by a person other than the gamete provider or the gamete provider's spouse. (2B) The counselling services under subsection (2A) must— (a) be available at the premises of the ART provider, and (b) be offered before the gamete or embryo is used. (2C) Counselling services under this section must be provided by a person with the qualifications (if any) prescribed by the regulations. (3) Nothing in this section— (a) prevents a person who provides the counselling service from charging a reasonable fee for that service, or (b) requires a person to make use of the counselling service. 13 Provision of information to participants in ART services (1) An ART provider must, in accordance with this section— (a) inform a person specified in Column 1 of the Table to this subsection of the matters specified opposite in Column 2, and (b) obtain confirmation from the person that the person understands those matters, before providing an ART service specified opposite in Column 3. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. Table Column 1 Column 2 Column 3 Person Matters ART service 1 A woman seeking ART treatment that does not use donated gametes Basic list of matters ART treatment to the woman 2 A woman seeking ART treatment that uses donated gametes Extended list of matters ART treatment to the woman 3 A person proposing to provide a gamete (other than as a donated gamete) Basic list of matters Obtaining the gamete from the person 4 A person proposing to provide a donated gamete Extended list of matters Obtaining the gamete from the person 5 A gamete provider from whom the gamete was not originally obtained as a donated gamete Extended list of matters Using the gamete, or an embryo created using the gamete, in providing ART treatment to a person who is not the gamete provider or the gamete provider's spouse (2) The basic list of matters that a person must be informed of under this section is as follows— (a) the availability of counselling services, (b) the effect of a gamete provider's consent under Division 3, and how and until when such a consent may be modified or revoked, (c) any other matter that is prescribed by the regulations. (3) The extended list of matters that a person must be informed of under this section is as follows— (a) the availability of counselling services, (b) the effect of a gamete provider's consent under Division 3, and how and until when such a consent may be modified or revoked, (c) the obligations of the ART provider in relation to obtaining information about the person and the person's offspring, (d) the application of section 62 to the person, including in relation to information provided to the ART provider by the person, (e) the existence of the central register and the information about the person and the person's offspring that will be held on the register, (f) the right of the person to obtain information held on the register about the person, (g) the right of the person and the person's offspring to obtain information held on the register about other persons, (h) the right of other persons to obtain information held on the register about the person and the person's offspring, (i) any other matter that is prescribed by the regulations. (4) Any information required to be provided under this section is to be provided in the approved form (if any). (5) Any confirmation required to be obtained under this section is to be obtained in the approved form (if any). 14 (Repealed) 15 Donated gametes—disclosure of medical information (1) An ART provider may disclose medical information— (a) about a donor— (i) to an adult offspring born as a result of ART treatment using the donor's donated gamete, or (ii) to the parent of an offspring born as a result of ART treatment using the donor's donated gamete, if the offspring is a child, or (iii) to a woman who is pregnant as a result of ART treatment using the donor's donated gamete, or (b) to a donor, about an offspring born as a result of ART treatment using the donor's donated gamete, if a registered medical practitioner has certified in writing that it is necessary to make the disclosure to save a person's life or to warn the person to whom the information is disclosed about the existence of a medical condition that may be harmful to that person or to that person's offspring (including any future offspring of the person). (2) If an ART provider discloses medical information under this section, the disclosure must be made by a registered medical practitioner on behalf of the ART provider. (3) If a disclosure may be made to a person under this section, the disclosure may also be made to a registered medical practitioner who is treating the person. (4) Nothing in this section requires an ART provider to disclose information to any person. 15A Assessment report in relation to surrogacy arrangements (1) An ART provider must not provide treatment to a woman that is intended to assist the woman to achieve pregnancy, and which is sought in connection with a surrogacy arrangement, unless the ART provider has been provided with an assessment report in relation to the surrogacy arrangement. Maximum penalty—100 penalty units in the case of a corporation or 50 penalty units in any other case. (2) A registered medical practitioner who undertakes or supervises the provision of ART services by an ART provider must ensure that any treatment intended to assist a woman to achieve pregnancy, and which is sought in connection with a surrogacy arrangement, is not provided to the woman unless the medical practitioner is satisfied it is appropriate to do so, having regard to an assessment report. (3) Contravention of subsection (2) is not an offence, but may constitute improper conduct by the medical practitioner for the purposes of the Health Practitioner Regulation National Law (NSW). (4) For the purposes of this section, an assessment report is a report by an independent counsellor about the surrogacy arrangement, that is based on interviews with the parties to the surrogacy arrangement. (5) An assessment report must include the independent counsellor's opinion as to whether the parties to the surrogacy arrangement understand the surrogacy arrangement, including the possible outcomes of the surrogacy arrangement, and are suitable persons to enter into or continue with the surrogacy arrangement. (6) An assessment report must address such other matters as the regulations require the report to address. (7) An ART provider or medical practitioner does not contravene this section unless it is proved that the ART provider or medical practitioner knew, or should reasonably have suspected, that the treatment concerned was sought in connection with a surrogacy arrangement. (8) In this section— independent counsellor means a qualified counsellor (within the meaning of the Surrogacy Act 2010) who is not employed or engaged by the ART provider. Division 3 Use of gametes 16 Interpretation In this Division— (a) consent of a gamete provider means the gamete provider's consent given under section 17 in relation to a gamete as modified or revoked in accordance with that section, and (b) a requirement that any matter be consistent with a gamete provider's consent is, if gametes from more than one gamete provider are involved, a requirement that the matter be consistent with each gamete provider's consent. 17 Giving, modifying and revoking consent (1) A gamete provider may give an ART provider that obtains, or proposes to obtain, a gamete from the gamete provider a written notice, in the approved form (if any), setting out the gamete provider's wishes in relation to the gamete (the gamete provider's consent). (2) A gamete provider's consent may address such matters as the uses that may be made of the gamete (or an embryo created using the gamete) and whether the gamete or embryo may be stored, exported from this State or supplied to another ART provider. (3) A gamete provider may modify or revoke his or her consent by giving written notice, in the approved form (if any), of the modification or revocation of consent to— (a) the ART provider that obtained the gamete from the gamete provider, or (b) any ART provider that is, or has ever been, in possession of the gamete or embryo to which the modification or revocation of consent relates. (4) A consent may be modified or revoked at any time up until— (a) in the case of a donated gamete—the gamete is placed in the body of a woman or an embryo is created using the gamete, or (b) in the case of a gamete that is used to create a donated embryo—the embryo is implanted in the body of a woman, or (c) in any other case—the gamete is placed in the body of a woman or an embryo created using the gamete is implanted in the body of a woman. (5) As soon as practicable after an ART provider is given written notice by a gamete provider of the modification or revocation of his or her consent, the ART provider must give written notice of the modification or revocation to any other ART provider to which the ART provider has supplied the gamete or any embryo created using the gamete. (6) As soon as practicable after an ART provider is given written notice by another ART provider of the modification or revocation of a gamete provider's consent, the ART provider must give written notice of the modification or revocation to any other ART provider to which the ART provider has supplied the gamete or any embryo created using the gamete. (7) Except as provided by section 17A, a modification or revocation of consent takes effect in relation to an ART provider as soon as the ART provider is given written notice of the modification or revocation in accordance with this section. (8) A reference in this section to a donated gamete does not include a reference to a gamete that becomes a donated gamete only after being used to create an embryo. 17A Verification of identify of person giving, modifying or revoking consent (1) An ART provider that is given a written notice under section 17 must take the following steps to verify the identity of the person purportedly giving the consent to which the notice relates— (a) the steps (if any) prescribed by the regulations, (b) if there are no steps prescribed by the regulations, reasonable steps. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. (2) A gamete provider's consent has no effect in relation to an ART provider that is required to comply with subsection (1) in connection with that consent until the ART provider so complies. (3) An ART provider that is given a written notice under section 17 (5) or (6) is not required to comply with subsection (1) in connection with the modification or revocation to which the notice relates if the ART provider has reasonable grounds to believe that another ART provider has already complied with subsection (1) in connection with the modification or revocation. (4) In this section, consent includes the modification or revocation of consent. 17B ART provider to take steps to obtain confirmation of consent in certain cases (1) An ART provider must not carry out any of the following activities in respect of a gamete or embryo (other than a donated gamete or donated embryo) unless the ART provider has taken the required steps, in accordance with this section, to obtain confirmation of the gamete provider's consent to the activity concerned— (a) use the gamete to create an embryo outside the body of a woman, (b) provide ART treatment to a woman using the gamete or embryo, (c) supply the gamete or embryo to another person (including an ART provider), (d) export, or cause to be exported, the gamete or embryo from this State. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. (2) The required steps are the steps (if any) prescribed by the regulations or, if there are no steps prescribed by the regulations, reasonable steps. (3) The ART provider must take the required steps no earlier than the period of time, determined in accordance with the regulations, before the activity concerned. (4) An ART provider is not required to comply with this section— (a) if the ART provider knows or believes on reasonable grounds that the gamete provider is deceased, or (b) in any other circumstances prescribed by the regulations. 18 Use of gametes to create embryo outside a woman's body An ART provider must not use a gamete to create an embryo outside the body of a woman except with the consent of the gamete provider and in a manner that is consistent with the gamete provider's consent. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. Note— Section 9 of the Human Cloning for Reproduction and Other Prohibited Practices Act 2003 provides that a person commits an offence if the person intentionally develops a human embryo outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended. 19 Use of gametes or embryos in ART treatment An ART provider must not provide ART treatment to a woman using a gamete except with the consent of the gamete provider and in a manner that is consistent with the gamete provider's consent in relation to— (a) the ART treatment or classes of ART treatment for which the gamete may be used, and (b) the woman or classes of women who may receive ART treatment using the gamete. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. 20 Use of gametes or embryos for research An ART provider must not use a gamete or an embryo for research except with the consent of the gamete provider and in a manner that is consistent with the gamete provider's consent. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. Note— See also the Research Involving Human Embryos Act 2002 of the Commonwealth which regulates research in relation to embryos. 21 Supply of gametes or embryos to another person An ART provider must not supply a gamete or an embryo to another person (including another ART provider) except with the consent of the gamete provider and in a manner that is consistent with the gamete provider's consent. Maximum penalty—800 penalty units in the case of a corporation or 400 penalty units in any other case. 22 Export of gametes or embryos from NSW An ART provider must not export, or cause to be exported, a gamete or an embryo from this State except with the consent of the gamete provider and in a manner that is consistent with the gamete provider's consent. Maximum penalty—400 penalty units in the case of a corporation or 200 penalty units in any other case. 23 Use of gametes or embryos after death of gamete provider An ART provider must not provide ART treatment to a woman using a gamete if the ART provider knows or believes on reasonable grounds that the gamete provider is deceased, unless— (a) the gamete provider has consented to the use of the gamete after his or her death, and (b) the woman receiving the ART treatment has been notified of the death or suspected death of the gamete provider and the date of death (if known), and (c) the woman receiving the ART treatment has given written consent to the provision of the ART treatment using the gamete despite the death or suspected death of the gamete provider. Maximum penalty—400 penalty units in the case of a corporation or 200 penalty units in any other case. Note— The Human Tissue Act 1983 regulates the removal of tissue (including gametes) from a deceased person. 24 Use of gametes or embryos provided more than 5 years ago (1) An ART provider must not provide ART treatment using a gamete obtained from a gamete provider more than 5 years before the provision of the ART treatment, unless the ART provider has taken reasonable steps to establish whether the gamete provider is alive. Maximum penalty—400 penalty units in the case of a corporation or 200 penalty units in any other case. (2) Despite subsection (1) an ART provider